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    Summary
    EudraCT Number:2009-012989-30
    Sponsor's Protocol Code Number:MS-LAQ-301E
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-012989-30
    A.3Full title of the trial
    A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in subjects with multiple sclerosis who successfully
    completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of
    laquinimod (experimental drug) when taken for a long period of time and
    how it affects the course of the disease.
    A.3.2Name or abbreviated title of the trial where available
    -
    A.4.1Sponsor's protocol code numberMS-LAQ-301E
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Pharmaceutical Industries Ltd
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTeva Pharmaceuticals Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number000000000000
    B.5.5Fax number000000000000
    B.5.6E-mailinfo.era-clinical@teva.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLaquinimod Capsules 0.6 mg
    D.3.2Product code TV-5600
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlaquinimod
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameABR-215062 sodium salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.

    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting multiple sclerosis is a chronic inflammatory disease that affects the central nervous system.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ancillary studies described within the core protocol will be performed in a subset of subjects:
    MRI: Subjects who participated in the Frequent MRI ancillary study during the MS-LAQ-301
    study will be offered to continue to undergo MRI scans during the open-label extension study.
    During the MS-LAQ-301E study, these scans will be performed at Months 0E [Baseline (This is
    the Termination scan of the MS-LAQ-301 study)] and then every 12 months thereafter, until
    Termination/Early discontinuation.
    Magnetization Transfer (MT): Subjects who participated in the MT ancillary study during the
    MS-LAQ-301 study will be offered to continue to undergo MT scans during the open-label
    extension study. During the MS-LAQ-301E study, these scans will be performed at Months 0E
    [Baseline (Termination visit of the MS-LAQ-301 study)] (this scan is a part of the MT ancillary
    study under the MS-LAQ-301 protocol) and then every 12 months thereafter until
    Termination/Early discontinuation.
    Magnetic Resonance Spectroscopy (MRS): Subjects who participated in the MRS ancillary study
    during the MS-LAQ-301 study will be offered to continue to undergo MRS scans during the
    open-label extension study. During the MS-LAQ-301E study, these scans will be performed at
    Months 0E [Baseline (Termination visit of the MS-LAQ-301 study)] (this scan is a part of the
    MRS ancillary study under the MS-LAQ-301 protocol) and then every 24 months thereafter,
    until Termination/Early discontinuation.
    E.3Principal inclusion criteria
    1.Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
    2. Women of child-bearing potential (for example women who are not
    postmenopausal or surgically sterilized) must practice two acceptable
    methods of birth control for the duration of the study and until 30 days
    after the last dose of study medication [acceptable methods of birth
    control in this open label extension phase include: intrauterine devices,
    barrier methods (condom or diaphragm with spermicide), and hormonal
    methods of birth control (e.g. oral contraceptive, contraceptive patch,
    and long-acting injectable contraceptive)].
    3.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
    4.Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1.Premature discontinuation from the MS-LAQ-301 study, for any reason.
    2.Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
    3.Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
    4.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature.
    The outcome measures are as follows:

    1.To assess the long-term safety and tolerability of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
    Safety and Tolerability Outcome Measures:
    Safety:
    Adverse events
    Vital signs
    ECG findings
    Clinical laboratory parameters

    Tolerability:
    Proportion of subjects (%) who prematurely discontinued from the study, reason of discontinuation and the time to withdrawal.
    Proportion of subjects (%) who prematurely discontinued from the study due to AEs and the time to withdrawal

    2.To assess the long-term effect of laquinimod 0.6 mg on disease course, as assessed by several parameters:
    Number of confirmed relapses
    Progression of disability as measured by the EDSS score (including FS and AI)
    Progression of disability as measured by the MSFC score
    Binocular low-contrast visual acuity using the 100%, 2.5% and 1.25% contrast level charts [Sloan letter (Appendix 9) or Tumbling-E (Appendix 10)]
    Subject-reported fatigue as assessed by the Modified Fatigue Impact Scale (MFIS)


    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of confirmed relapses:
    -On-Study Relapse Evaluation throughout the treatment duration
    Subjects will be instructed to telephone their study site within 48 hours
    should any symptoms suggestive of a relapse appear.
    The Treating Neurologist/ Physician will evaluate the
    subject once any symptom suggestive of a relapse occurs.
    All other parameters:
    -At Months 0 Baseline [(Termination visit of the MS-LAQ-301 study)],
    and month 6 and every 6 months thereafter.
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    long-term effect on disease course
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Israel
    Russian Federation
    Serbia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    In this open-label study, the subjects will be treated with Laquinimod 0.6 mg as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 632
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 391
    F.4.2.2In the whole clinical trial 632
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Laquinimod 0.6 mg if commercially available for the
    treatment of MS patients or normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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